Academic authors have retracted the pivotal phase 3 study article for Amgen’s Tavneos (avacopan) from The New England Journal of Medicine after primary endpoint assessments for nine patients were re-adjudicated post-database lock and after unblinding. The retraction notice ties the procedural changes to concerns about whether results were handled appropriately relative to standard research conduct. The retraction compounds existing regulatory and legal pressure around Tavneos, which was approved by FDA in 2021 for ANCA-associated vasculitis. Amgen has indicated it is preparing to respond through FDA processes and has highlighted its own re-adjudication efforts.